DTC Pre-review Requirement Broadly Defined Under FDA Draft Guidance
This article was originally published in The Pink Sheet Daily
The agency’s draft guidance on prereview of television advertisements also requires companies to submit the information they rely on to support claims in an ad.
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The two divisions within the Office of Prescription Drug Promotion are renamed the divisions of advertising and promotion review I and II; they will each have four teams operating within them in a structure akin to the Office of New Drugs.
FDA is proposing changes to its regulation of television advertising for prescription drugs with a mandatory pre-review of ads for certain products. The agency says it has the resources to complete all reviews on time. But stakeholders worry that the draft requirements would delay campaigns and make DTC advertising more expensive. It’s not like there’s a good alternative: jumping the gun on DTC carries its own set of risks.
A draft guidance that outlines six categories of drug ads FDA wants submitted for prior review is a violation of advertisers’ free speech rights, the industry group argues. Other comments float a storyboard compromise.